A Bill for an Act
Page 1, Line 101Concerning the creation of a drug donation program.
Bill Summary
(Note: This summary applies to this bill as introduced and does not reflect any amendments that may be subsequently adopted. If this bill passes third reading in the house of introduction, a bill summary that applies to the reengrossed version of this bill will be available at http://leg.colorado.gov.)
The bill amends statutory provisions relating to unused medication in facilities, including correctional facilities, nursing care facilities, assisted living residences, hospice, and other facilities, to change the defined term "medication" to "medicine" and to expand the types of unused medicines that may be redispensed to patients or donated to a nonprofit entity.
The bill creates the Colorado drug donation program (donation program). The donation program allows a person legally authorized to possess medicine, including an individual member of the public, a pharmacy, a long-term care facility, a surgical center, a prescriber or other health-care professional or facility, or others (donor) to donate unused medicine (donated medicine).
A donor may donate unused medicine to a donation recipient (donation recipient) that is authorized to possess medicine and that has a credential in good standing in the state in which the donation recipient is located. A donation recipient may include a wholesaler, distributor, third-party logistics provider, repackager, hospital, pharmacy, clinic, health-care provider, or prescriber's office.
The bill requires the donation recipient to:
- Keep a record of the donated medicine;
- Keep donated medicine separate from regular stock; and
- Have donated medicine inspected by a licensed pharmacist.
The donation recipient may transfer the donated medicine to another donation recipient or entity, repackage the donated medicine, or, if the donation recipient is a prescription drug outlet, replenish medicine.
The bill requires donated medicine to first be dispensed to an eligible patient who is an individual who is indigent, uninsured, underinsured, or enrolled in a public health benefits program. Donated medicine must not be resold; except that a donation recipient may charge a handling or dispensing fee for the donated medicine.
When acting in good faith, the participants in the donation program are not subject to criminal liability or professional disciplinary action.
This Unofficial Version Includes Committee
Amendments Not Yet Adopted on Second Reading
Page 2, Line 1Be it enacted by the General Assembly of the State of Colorado:
Page 2, Line 2SECTION 1. In Colorado Revised Statutes, 12-280-135, amend
Page 2, Line 3(1)(e), (2)(a), (2)(b) introductory portion, (2)(b)(II), (2)(b)(III), (2)(c)
Page 2, Line 4introductory portion, (2)(c)(I), (2)(c)(III), (2)(c)(V), (3), (4), and (6);
Page 2, Line 5repeal (2)(c)(IV) and (5); and add (2)(b)(IV), (2)(c)(VI), (2)(c)(VII), and (2)(c)(VIII) as follows:
Page 2, Line 612-280-135. Unused medicine - licensed facilities - correctional
Page 2, Line 7facilities - reuse - definitions - rules. (1) As used in this section, unless the context otherwise requires:
Page 2, Line 8(e) (I)
"Medication" means a prescription that is not a controlledPage 2, Line 9
substance(II) "Medicine" includes:
Page 3, Line 1(A) A prescription drug that requires refrigeration,
Page 3, Line 2freezing, or special storage if the prescription drug has been
Page 3, Line 3continually maintained by a donor pursuant to the
Page 3, Line 4manufacturer's storage requirements, so long as the cold chain can be verified; and
Page 3, Line 5(B) Prescription supplies and devices.
(III) "Medicine" does not include:
Page 3, Line 6(A) Compounded drugs;
Page 3, Line 7(B) Prescription drugs dispensed by pharmacies outside of the United States;
Page 3, Line 8(C) Prescription drugs that are subject to risk evaluation
Page 3, Line 9and mitigation strategies (REMS) under 21 U.S.C. sec. 355-1 (f)(3)
Page 3, Line 10unless all of the required guidelines for the medicine are
Page 3, Line 11followed or REMS drugs that were initially dispensed by a
Page 3, Line 12pharmacy pursuant to a restricted REMS distribution channel; or
Page 3, Line 13(D) Controlled substances.
Page 3, Line 14(2) (a) (I) If donated by the patient, the resident, or the patient's or
Page 3, Line 15resident's next of kin, a licensed facility may return unused
medicationsPage 3, Line 16medicine or medical supplies and used or unused medical devices to a
Page 3, Line 17pharmacist within the licensed facility or a prescription drug outlet in
Page 3, Line 18order for the materials to be redispensed to another patient or donated to
Page 3, Line 19a nonprofit entity that has the legal authority to possess the materials or to a practitioner authorized by law to dispense the materials.
Page 3, Line 20(II) (A) A licensed facility or a prescription drug outlet may
Page 3, Line 21donate materials to
a nonprofitPage 4, Line 1possess the materials or to a person legally authorized to dispense the
Page 4, Line 2materials. A licensed pharmacist shall review the process of donating the unused
medicationsnonprofitPage 4, Line 3(B) Nothing in this subsection (2)(a)(II) creates or abrogates any
Page 4, Line 4liability on behalf of a prescription drug manufacturer for the storage,
Page 4, Line 5donation, acceptance, or dispensing of
a medicationPage 4, Line 6product or creates any civil cause of action against a prescription drug manufacturer in addition to that which is available under applicable law.
Page 4, Line 7(C) A person or entity is not subject to civil or criminal liability
Page 4, Line 8or professional disciplinary action for donating, accepting, dispensing, or
Page 4, Line 9facilitating the donation of materials in good faith, without negligence or willful or wanton misconduct, and in compliance with this section.
Page 4, Line 10(III) A correctional facility may return unused
medicationsPage 4, Line 11medicine or medical supplies and used or unused medical devices to the
Page 4, Line 12pharmacist within the correctional facility or a prescription drug outlet in
Page 4, Line 13order for the
medicationPage 4, Line 14donated to
a nonprofitPage 4, Line 15(b)
Medications arePage 4, Line 16another person or donated to
a nonprofitmedications arePage 4, Line 17(II) Individually packaged and the packaging has not been damaged;
orPage 4, Line 18(III) In
the original,sealed, andunit dosePage 4, Line 19(IV) For medicine that requires refrigeration, freezing, or
Page 4, Line 20special storage, continually maintained by the donor pursuant
Page 5, Line 1to the manufacturer's storage requirements, so long as the cold chain can be verified.
Page 5, Line 2(c) The following
medications may not be donatedPage 5, Line 3(I)
MedicationsPage 5, Line 4
brown or amber pill bottlesPage 5, Line 5(III)
MedicationsPage 5, Line 6of this section, medicine that
requirePage 5, Line 7(IV)
Medications that require special registration with the manufacturer; orPage 5, Line 8(V)
MedicationsarePage 5, Line 9as determined by a person legally authorized to dispense the
medicationsPage 5, Line 10medicine on behalf of the nonprofit entity or a person legally authorized to dispense the medicine;
Page 5, Line 11(VI) Compounded medicine;
Page 5, Line 12(VII) Medicine dispensed by pharmacies outside of the United States; or
Page 5, Line 13(VIII) Medicine that is subject to risk evaluation and
Page 5, Line 14mitigation strategies (REMS) under 21 U.S.C. sec. 355-1 (f)(3)
Page 5, Line 15unless all of the required guidelines for the medicine are
Page 5, Line 16followed or REMS drugs that were initially dispensed by a pharmacy pursuant to a restricted REMS distribution channel.
Page 5, Line 17(3)
MedicationPage 5, Line 18section must not be expired. A
medication shall not be dispensedPage 5, Line 19prescribing practitioner shall not dispense medicine that will
Page 6, Line 1expire before the use by the patient based on the prescribing practitioner's directions for use.
Page 6, Line 2(4)
MedicationPage 6, Line 3donated pursuant to this section
mayfor profit. ThePage 6, Line 4
entity that receives the donated materials may charge the end user aPage 6, Line 5
handling fee, which fee shall not exceed the amount specified by rule ofPage 6, Line 6
the boardPage 6, Line 7dispensing, or usual and customary charges to an eligible
Page 6, Line 8patient, health plan, pharmacy benefit manager, pharmacy
Page 6, Line 9service, administrative organization, government agency, or
Page 6, Line 10other entity is not considered reselling. If the donation
Page 6, Line 11recipient is a for-profit entity, these charges must not exceed
Page 6, Line 12the donation recipient's cost of providing the medicine, including
Page 6, Line 13the current and anticipated costs of educating eligible donors
Page 6, Line 14and individual donors, providing technical support to
Page 6, Line 15participating donors and individual donors, shipping and
Page 6, Line 16handling, labor, storage, licensing, utilities, advertising,
Page 6, Line 17technology, supplies, and equipment. Except as described in this
Page 6, Line 18subsection (4), the amount of these charges is not subject to additional limitations.
Page 6, Line 19(5)
The board shall adopt rules that allow a pharmacist toPage 6, Line 20
redispense medication pursuant to this section and section 25.5-5-502 and to donate medication pursuant to this section.Page 6, Line 21(6) (a) Except as provided in subsection (6)(b) of this
Page 6, Line 22section, nothing in this section or section 25.5-5-502 creates or
Page 6, Line 23abrogates any liability on behalf of a prescription drug manufacturer for
Page 6, Line 24the storage, donation, acceptance, or dispensing of
anPage 7, Line 1
medicationPage 7, Line 2prescription drug manufacturer in addition to that which is available under applicable law.
Page 7, Line 3(b) A manufacturer of a prescription drug that is subject
Page 7, Line 4to risk evaluation and mitigation strategies (REMS) is not
Page 7, Line 5subject to criminal prosecution or liability in tort or other civil
Page 7, Line 6action for injury, death, or loss to person or property for
Page 7, Line 7matters related to the donation, acceptance, or dispensing of a
Page 7, Line 8REMS drug manufactured by the drug manufacturer that is
Page 7, Line 9donated by any person pursuant to the program, including
Page 7, Line 10liability for failure to transfer or communicate product or
Page 7, Line 11consumer information or the expiration date of the donated prescription drug.
Page 7, Line 12SECTION 2. In Colorado Revised Statutes, add 12-280-135.5 as follows:
Page 7, Line 1312-280-135.5. Colorado drug donation program - created -
Page 7, Line 14rules - records - definitions. (1) As used in this section, unless the context otherwise requires:
Page 7, Line 15(a) "Colorado drug donation program" or "program"
Page 7, Line 16means the Colorado drug donation program created in this section.
Page 7, Line 17(b) "Controlled substance" has the meaning set forth in section 18-18-102.
Page 7, Line 18(c) (I) "Donation recipient" means an entity that:
(A) Is legally authorized to possess medicine;
Page 7, Line 19(B) Has a license or registration in good standing in the
Page 7, Line 20state in which the entity is located; and
(C) Receives a donation of medicine.
Page 8, Line 1(II) "Donation recipient" includes a hospital, a
Page 8, Line 2pharmacy, a clinic, a health-care provider, or a prescriber office.
Page 8, Line 3(III) "Donation recipient" also includes a wholesaler, a
Page 8, Line 4distributor, a third-party logistics provider, a reverse
Page 8, Line 5distributor, or a repackager if the entity is a nonprofit entity or
Page 8, Line 6is directly or indirectly owned, controlled, or could be controlled by a nonprofit entity.
Page 8, Line 7(d) (I) "Donor" means any entity legally authorized to
Page 8, Line 8possess medicine, including a wholesaler, a distributor, a
Page 8, Line 9third-party logistics provider, a pharmacy, a dispenser, a clinic,
Page 8, Line 10a surgical or health center, a rehabilitation center, a detention
Page 8, Line 11center, a jail, a prison, a laboratory, a prescriber or other
Page 8, Line 12health-care professional, a long-term care facility or
Page 8, Line 13health-care facility, and any other entity regulated by the board that donates medicine.
Page 8, Line 14(II) "Donor" includes government agencies and entities
Page 8, Line 15that are federally authorized to possess medicine, including
Page 8, Line 16manufacturers, repackagers, relabelers, outsourcing facilities,
Page 8, Line 17veterans affairs hospitals, FDA-authorized importers such as
Page 8, Line 18those described under the federal "Food, Drug, and Cosmetic
Page 8, Line 19Act", 21 U.S.C. secs. 801 and 804, as amended, or similar provisions, and federal prisons.
Page 8, Line 20(e) (I) "Eligible patient" means an individual with a need
Page 8, Line 21for donated medicine who is indigent, uninsured, or
Page 8, Line 22underinsured.
Page 9, Line 1(II) "Eligible patient" includes other individuals if a need
Page 9, Line 2for donated medicine is not identified among individuals who are indigent, uninsured, or underinsured.
Page 9, Line 3(f) "Health-care professional" means an individual who is
Page 9, Line 4licensed to practice as a physician, registered nurse, advanced
Page 9, Line 5practice registered nurse, practical nurse, optometrist, or
Page 9, Line 6pharmacist; a certified midwife with prescriptive authority
Page 9, Line 7pursuant to section 12-255-112; or any other practitioner authorized to dispense or administer medicine.
Page 9, Line 8(g) "Individual donor" means a nonlicensed individual member of the public.
Page 9, Line 9(h) (I) "Medicine" means prescription drugs.
(II) "Medicine" includes:
Page 9, Line 10(A) A prescription drug that requires refrigeration,
Page 9, Line 11freezing, or special storage if the medicine has been continually
Page 9, Line 12maintainedby the donor pursuant to the manufacturer's
Page 9, Line 13storage requirements, so long as the cold chain can be verified; and
Page 9, Line 14(B) Prescription supplies and devices.
(III) "Medicine" does not include:
Page 9, Line 15(A) Compounded drugs;
Page 9, Line 16(B) Prescription drugs dispensed by pharmacies outside of the United States;
Page 9, Line 17(C) Prescription drugs that are subject to risk evaluation
Page 9, Line 18and mitigation strategies (REMS) under 21 U.S.C. sec. 355-1 (f)(3)
Page 9, Line 19unless all of the required guidelines for the medicine are
Page 9, Line 20followed or REMS drugs that were initially dispensed by a
Page 10, Line 1pharmacy pursuant to a restricted REMS distribution channel; or
Page 10, Line 2(D) Controlled substances.
Page 10, Line 3(i) "Prescriber" has the meaning set forth in section 12-280-125.7 (1)(f).
Page 10, Line 4(j) "Returns processor" has the meaning set forth in 21 U.S.C. sec. 360eee (18) and includes a reverse distributor.
Page 10, Line 5(k) (I) "Unopened, tamper-evident packaging" means an
Page 10, Line 6intact packaging system that renders medicine inaccessible
Page 10, Line 7without obvious destruction of the seal or some portion of the packaging system.
Page 10, Line 8(II) "Unopened, tamper-evident packaging" may include
Page 10, Line 9unopened unit-dose, multiple-dose, immediate, secondary, or tertiary packaging.
Page 10, Line 10(2) There is created the Colorado drug donation program
Page 10, Line 11to facilitate the safe donation and redispensing of unused
Page 10, Line 12medicine to Coloradans in need of the medicine. Participation in the program is voluntary.
Page 10, Line 13(3) (a) Notwithstanding any other law or rule to the
Page 10, Line 14contrary, a donor or an individual donor may donate medicine
Page 10, Line 15to a donation recipient. A donation recipient may receive donated medicine from a donor or an individual donor.
Page 10, Line 16(b) Prior to the first donation from a person, a donation
Page 10, Line 17recipient shall record the person's name, address, phone number, and license number, if applicable, and shall:
Page 10, Line 18(I) Verify that the person meets the definition provided in
Page 10, Line 19subsection (1)(d) of this section;
Page 11, Line 1(II) Confirm that the person agrees to make donations of
Page 11, Line 2medicine only in accordance with this section and rules adopted by the board relating to donated medicine; and
Page 11, Line 3(III) If applicable, confirm that the person agrees to
Page 11, Line 4remove or redact any patient names and prescription numbers on
Page 11, Line 5donated medicine or to otherwise maintain patient
Page 11, Line 6confidentiality by executing a confidentiality agreement with the authorized donation recipient.
Page 11, Line 7(c) No other information or records are required prior to
Page 11, Line 8the first donation from a new donor or a new individual donor other than as described in subsection (3)(b) of this section.
Page 11, Line 9(4) A donation recipient shall maintain a written or an
Page 11, Line 10electronic record of donated medicine consisting of the name,
Page 11, Line 11strength, quantity, and lot number, if known, of each accepted
Page 11, Line 12or transferred drug and the name, address, and phone number of
Page 11, Line 13the donor, individual donor, or transferring entity. No other record of donation is required.
Page 11, Line 14(5) A donation recipient shall ensure that donated
Page 11, Line 15medicine is identified physically or electronically as separate from regular stock.
Page 11, Line 16(6) Notwithstanding any other law to the contrary, a donation recipient may:
Page 11, Line 17(a) Transfer donated medicine to another donation
Page 11, Line 18recipient or to an entity participating in a drug donation program operated by another state;
Page 11, Line 19(b) Repackage donated medicine in accordance with
Page 11, Line 20subsection (8) of this section as necessary for storage, dispensing, administration, or transfer; or
Page 12, Line 1(c) If the donation recipient is a prescription drug outlet
Page 12, Line 2or other outlet, replace medicine of the same drug name and
Page 12, Line 3strength previously dispensed or administered to eligible patients in accordance with 42 U.S.C. sec. 256b, as amended.
Page 12, Line 4(7) (a) Donated medicine that does not meet the
Page 12, Line 5requirements specified in this section and the rules adopted by the board must be disposed of by:
Page 12, Line 6(I) Returning the donated medicine to the donor;
Page 12, Line 7(II) Destroying the donated medicine through an
Page 12, Line 8incinerator, a medical waste hauler, a reverse distributor, or other lawful method; or
Page 12, Line 9(III) Transferring the donated medicine to a returns processor.
Page 12, Line 10(b) A donation recipient shall maintain a written or an
Page 12, Line 11electronic record of disposed medicine consisting of the disposal
Page 12, Line 12method, as described in subsection (7)(a) of this section; the date
Page 12, Line 13of disposal; and the name, strength, and quantity of each disposed drug. No other record of disposal is required.
Page 12, Line 14(8) Repackaged medicine must be labeled with the drug
Page 12, Line 15name, strength, and expiration date, if the expiration date is
Page 12, Line 16known, and identified separately from regular stock until
Page 12, Line 17inspected and initialed by a licensed pharmacist. If multiple
Page 12, Line 18packaged, donated medicines with varied expiration dates are
Page 12, Line 19repackaged together, the earliest expiration date must be used.
Page 12, Line 20Prescription drugs specified by NDC number in a recall notice
Page 12, Line 21must be considered recalled unless the prescription drug has an affixed lot number that excludes it from the recall.
Page 13, Line 1(9) A donation recipient shall only administer or redispense medicine that:
Page 13, Line 2(a) Is in unopened, tamper-evident packaging or has been repackaged under this program;
Page 13, Line 3(b) Meets the requirements set forth in this section based on an inspection by a licensed pharmacist;
Page 13, Line 4(c) If dispensed to an eligible patient, is repackaged by a
Page 13, Line 5licensed pharmacist into a new container or, if kept in the
Page 13, Line 6donated container, is in a container that has all previous patient information redacted or removed;
Page 13, Line 7(d) Is properly labeled in accordance with the rules adopted by the board;
Page 13, Line 8(e) Has an expiration or beyond-use date that will not
Page 13, Line 9expire before the medicine is used by the eligible patient based on the prescriber's directions for use; and
Page 13, Line 10(f) If the medicine requires refrigeration, freezing, or
Page 13, Line 11special storage, has been continually maintained by the donor
Page 13, Line 12pursuant to the manufacturer's storage requirements, so long as the cold chain can be verified.
Page 13, Line 13(10) A donation recipient:
Page 13, Line 14(a) May dispense or administer prescription drugs to an
Page 13, Line 15eligible patient pursuant to this section only if otherwise
Page 13, Line 16permitted by law pursuant to a valid prescription or prescription drug order; and
Page 13, Line 17(b) Shall maintain eligible patient-specific written or
Page 13, Line 18electronic records in accordance with rules adopted by the board.
Page 14, Line 1(11) A manufacturer, prescription drug outlet,
Page 14, Line 2repackager, dispenser, or wholesaler, other than a returns
Page 14, Line 3processor, participating in the program shall comply with the
Page 14, Line 4requirements of 21 U.S.C. secs. 360eee-1 to 360eee-4 relating to drug supply chain security.
Page 14, Line 5(12) The donation, transfer, or receipt of medicine or the
Page 14, Line 6facilitation of a donation, transfer, or receipt of medicine
Page 14, Line 7pursuant to this section is not wholesale distribution and does not require licensing as a wholesale distributor.
Page 14, Line 8(13) Medicine donated to the program must not be resold
Page 14, Line 9and is considered nonsaleable; except that handling, dispensing,
Page 14, Line 10or usual and customary charges to an eligible patient, health
Page 14, Line 11plan, pharmacy benefit manager, pharmacy services
Page 14, Line 12administrative organization, government agency, or other
Page 14, Line 13entity is not considered reselling. If the donation recipient is a
Page 14, Line 14for-profit entity, these charges must not exceed the donation
Page 14, Line 15recipient's cost of providing the medicine, including the current
Page 14, Line 16and anticipated costs of educating eligible donors and
Page 14, Line 17individual donors, providing technical support to participating
Page 14, Line 18donors and individual donors, shipping and handling, labor,
Page 14, Line 19storage, licensing, utilities, advertising, technology, supplies,
Page 14, Line 20and equipment. Except as described in this subsection (13), the
Page 14, Line 21amount of these charges is not subject to any additional limitations.
Page 14, Line 22(14) When performing any action associated with the
Page 14, Line 23program or otherwise processing donated medicine for tax, a
Page 15, Line 1manufacturer credit, or other credit, a donation recipient is
Page 15, Line 2considered to be acting as a returns processor and shall comply
Page 15, Line 3with all record-keeping requirements under federal law for nonsaleable returns.
Page 15, Line 4(15) All required records must be retained in physical or
Page 15, Line 5electronic format, on or off the donation recipient's premises,
Page 15, Line 6for a period of two years. Donors or donation recipients may
Page 15, Line 7contract with one another or with a third party to create or
Page 15, Line 8maintain records. An identifier, such as a serial number or bar
Page 15, Line 9code, may be used in place of information if it allows for the
Page 15, Line 10information to be readily retrievable. Upon request by a state
Page 15, Line 11or federal regulator, the identifier used for a requested record
Page 15, Line 12must be replaced with the original information. An identifier
Page 15, Line 13must not be used on labels when dispensing or administering a drug to an eligible patient.
Page 15, Line 14(16) A donation or other transfer of possession or
Page 15, Line 15control is not a change of ownership unless it is specified as such
Page 15, Line 16by the donation recipient. If a record of the donation's
Page 15, Line 17transaction information or history is required, the history must
Page 15, Line 18begin with the donor or individual donor, must include all prior
Page 15, Line 19donations, and, if the medicine was previously dispensed, must
Page 15, Line 20include only drug information that is required to be on the patient label in accordance with rules adopted by the board.
Page 15, Line 21(17) An entity participating in a drug donation or
Page 15, Line 22repository program operated by another state may participate
Page 15, Line 23in the program and, if the registered entity is a prescription drug
Page 15, Line 24outlet, may dispense donated drugs to eligible patients of this
Page 16, Line 1state. The registered entity is required to comply with all
Page 16, Line 2statutes and rules in this state unless the statutes or rules
Page 16, Line 3differ from or conflict with the statutes or rules of the state in which the entity is located.
Page 16, Line 4(18) The board shall adopt any rules necessary to
Page 16, Line 5implement this section. The rules must require the least amount
Page 16, Line 6of record keeping necessary to ensure patient safety and must allow flexibility in the format for record keeping.
Page 16, Line 7(19) Notwithstanding any law to the contrary, this
Page 16, Line 8section controls all activities under the program and supersedes any inconsistent law or rule.
Page 16, Line 9(20) When acting in good faith, without negligence or
Page 16, Line 10willful or wanton misconduct, the following individuals or
Page 16, Line 11entities are not subject to civil or criminal liability or professional disciplinary action:
Page 16, Line 12(a) An individual or entity involved in the supply chain of
Page 16, Line 13donated medicine, including the donor, the individual donor, the
Page 16, Line 14donation recipient, the manufacturer, the repackager, the
Page 16, Line 15prescription drug outlet or other entity regulated by the board, and the eligible patient;
Page 16, Line 16(b) An individual or entity, including an employee, an
Page 16, Line 17officer, a volunteer, an owner, a partner, a member, a director,
Page 16, Line 18a contractor, or other individual or entity associated with the
Page 16, Line 19individual or entity that, in compliance with this section,
Page 16, Line 20prescribes, donates, receives donations of, dispenses,
Page 16, Line 21administers, transfers, replaces, or repackages medicine or
Page 16, Line 22facilitates any of the actions described in this section; and
(c) The board.
Page 17, Line 1(21) Notwithstanding subsection (20) of this section, a
Page 17, Line 2manufacturer of a prescription drug that is subject to risk
Page 17, Line 3evaluation and mitigation strategies (REMS) is not subject to
Page 17, Line 4criminal prosecution or liability in tort or other civil action for
Page 17, Line 5injury, death, or loss to person or property for matters related
Page 17, Line 6to the donation, acceptance, or dispensing of a REMS drug
Page 17, Line 7manufactured by the drug manufacturer that is donated by any
Page 17, Line 8person pursuant to the program, including liability for failure
Page 17, Line 9to transfer or communicate product or consumer information or the expiration date of the donated prescription drug.
Page 17, Line 10(22) A donation recipient operating primarily for the
Page 17, Line 11purpose of participating in this program shall not be required to possess a comprehensive or minimum supply of medicine.
Page 17, Line 12SECTION 3. In Colorado Revised Statutes, 25-15-328, amend (6)(a) as follows:
Page 17, Line 1325-15-328. Household medication take-back program -
Page 17, Line 14creation - collection and disposal of medication injection devices - liability - definitions - cash fund - rules. (6) Nothing in this section:
Page 17, Line 15(a) Affects the authority to collect and reuse
medicationsPage 17, Line 17SECTION 4. Act subject to petition - effective date. This act
Page 17, Line 18takes effect at 12:01 a.m. on the day following the expiration of the
Page 17, Line 19ninety-day period after final adjournment of the general assembly; except
Page 17, Line 20that, if a referendum petition is filed pursuant to section 1 (3) of article V
Page 17, Line 21of the state constitution against this act or an item, section, or part of this
Page 18, Line 1act within such period, then the act, item, section, or part will not take
Page 18, Line 2effect unless approved by the people at the general election to be held in
Page 18, Line 3November 2026 and, in such case, will take effect on the date of the official declaration of the vote thereon by the governor.